From Columbia University College of Physicians & Surgeons and St. Luke's Roosevelt Hospital Center (RNR), New York, NY; Forest Laboratories, Inc. (AG, JLP), New York, NY; Lipha Pharmaceuticals, Inc. (AMG), New York, NY.
J Addict Med. 2008 Mar;2(1):40-50. doi: 10.1097/ADM.0b013e31816319fd.
Acamprosate, in conjunction with psychosocial treatment, has demonstrated efficacy in maintaining abstinence in alcohol-dependent patients in multiple clinical trials. Data from 13 short-term (≤26 weeks) and long-term (≥48 weeks) clinical trials were analyzed to assess the safety and tolerability of acamprosate: 4234 patients were randomized to placebo (N = 1962), acamprosate 1332 mg/d (N = 440), 1998 mg/d (N = 1749), or 3000 mg/d (N = 83). Overall incidence of treatment-emergent adverse events (AEs) was 61% for acamprosate and 56% for placebo (P < 0.01). The majority of AEs in all groups were reported as transient and considered "mild" or "moderate" in severity, and discontinuation rates due to AEs were comparable. Most common AEs were diarrhea (16% acamprosate versus 10% placebo, P < 0.01) and flatulence (3% acamprosate versus 2% placebo, P < 0.01). Patients taking concomitant medications commonly used to treat alcohol dependence reported comparable AEs between placebo- and acamprosate-treated groups.Acamprosate was shown to be safe in patients with hepatic impairment. A dose reduction is recommended in patients with renal impairment. No clinically meaningful between-group differences were reported for clinical chemistry tests or vital sign parameters. This ad hoc analysis demonstrates that acamprosate can be used safely in alcohol-dependent patients, including those taking concomitant medications, or having renal or hepatic impairment.
丙戊酸钠与心理社会治疗联合使用，已在多项临床试验中证明对酒精依赖患者维持戒酒有效。分析了 13 项短期（≤26 周）和长期（≥48 周）临床试验的数据，以评估丙戊酸钠的安全性和耐受性：4234 名患者被随机分配至安慰剂组（N=1962）、丙戊酸钠 1332mg/d 组（N=440）、1998mg/d 组（N=1749）或 3000mg/d 组（N=83）。丙戊酸钠组治疗中出现的不良事件（AE）总发生率为 61%，安慰剂组为 56%（P<0.01）。所有组中大多数 AE 均为一过性，且被认为严重程度为“轻度”或“中度”，因 AE 而停药的比例相当。最常见的 AE 为腹泻（丙戊酸钠组为 16%，安慰剂组为 10%，P<0.01）和肠胃气胀（丙戊酸钠组为 3%，安慰剂组为 2%，P<0.01）。同时使用常用于治疗酒精依赖的伴随药物的患者，报告的安慰剂和丙戊酸钠治疗组间 AE 相似。在肝损伤患者中，丙戊酸钠显示安全。对于肾损伤患者，建议减少剂量。临床化学检验或生命体征参数未报告有临床意义的组间差异。这项特别分析表明，丙戊酸钠可安全用于酒精依赖患者，包括同时使用伴随药物、或有肾或肝损伤的患者。
